GUEST CONTRIBUTORS

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Bioprocessing Trends To Watch In 2018
    Bioprocessing Trends To Watch In 2018

    Although it has remained relatively insulated from broader worldwide economic trends, the biopharmaceutical industry continues to focus on improved bioprocessing technologies to reduce costs and increase efficiencies. Targeting improvements in production can not only lower operational costs, it also can improve weak development pipelines, especially in developing economies.

  • How To Engage Regulators To Reduce Biopharma Manufacturing Timelines
    How To Engage Regulators To Reduce Biopharma Manufacturing Timelines

    Part 1 of this two-part Q&A explored the ways in which the FDA encourages innovation, the role of the agency’s Emerging Technology Team (ETT) in manufacturing innovation, and the innovation-safety balance for rare or orphan disease treatments. In this installment, the experts discuss whether compounding pharmacies can help enable iterative development, the feasibility of just-in-time drug manufacturing, and recommendations for speeding materials release.

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PHARMA OUTSOURCING WHITE PAPERS

Insights And Tips When Addressing Bioburden Challenges Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

Four Reasons For The Rise In Blister Packaging

Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.

Speed Up The Pace Of Chemical Research And Development

Today’s chemical development labs are busy places that create fascinating new chemicals, new formulations and new products that boost the bottom line. But are these labs as efficient as they could be?

Securing The Global Pharmaceutical Supply Chain Against The Threat Of Counterfeit Drugs

According to the World Health Organization (WHO), the prevalence of spurious, falsely-labelled, falsified, or counterfeit medicines, or SFFC medicines as they are known — medicines that are deliberately and fraudulently produced, packaged and/or mislabeled — is a growing trend worldwide which threatens both patient safety as well as public confidence in the health systems and regulatory bodies designed to provide oversight and control.

Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Efficient, High-Titer Monoclonal Antibody Production In A Fed-Batch Process

This application note shows the feasibility of monoclonal antibody (MAb) production in fed-batch processes using the single-use Xcellerex™ XDR-200 stirred-tank and ReadyToProcess WAVE™ 25 rocking bioreactor systems.

Innovation With Single-Use: Merck Calls For Collaboration To Overcome Challenges

As the industry — and Merck — sees its pipelines expanding into these more targeted areas of treatment, the call for flexibility and speed gets even louder. Many feel an answer to this is single-use technology (SUT). At Merck, there has been a continued momentum of sales in biologics and vaccines over the last 15 years. However, we had not fully explored SUT or its full potential implementation in our facilities. That is, until an outside industry expert gave us the brutally honest assessment that we were “behind” when it came to SUT.

Mixing And Heating-Cooling Characterization Data For Single-Use Mixer

This application note describes mixing and heating-cooling characterization data for the Xcellerex XDM 50 single-use mixer. A design of experiments approach to liquid-liquid mixing was successfully applied to establish a model to predict the mixing time throughout the working range.

Achieve Continuous Supply Of Drug Treatment For Study Requirements

A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Auditing Validated Computer Systems In A GxP Environment December 12, 2017
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template December 18, 2017
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Renovating Pharmaceutical Manufacturing Facilities for Aseptic Fill/Finish: Critical Planning, Execution & Compliance Tips January 10, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Introductory Rate
Stability Programs - Key Factors in Meeting FDA/ICH Expectations January 17, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
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